Focusing on lung and inhalation, Fraunhofer ITEM has pooled its expertise in three business units:
In the business unit Drug Development, we develop and test novel medications against respiratory diseases.
Scientific expertise covers manufacturing of biologics, preclinical and clinical development.
The business unit Chemical Safety is dedicated to determining the risks from potentially harmful substances.
The business unit Translational Biomedical Engineering offers many years of experience in the development of medical devices
– specifically neuro-implants and medical aerosolizers. All business units offer regulatory support.
Numerous test systems are available, including in-vitro, ex-vivo and in-vivo. Studies can be performed in compliance with GXP regulations.
The division of Personalized Tumor Therapy develops diagnostic tests to enable early detection of disseminated cancer cells and prediction of the response to therapy of metastatic progenitor cells.
Precision-cut lung slices (PCLS)
PCLS give direct insight into the cell-cell interactions in the living lungs of laboratory animals or humans. The PCLS technique enables investigations into the sensitizing and immunotoxic effects of substances and also into the effects of medications administered by inhalation.
To accelerate the manufacturing processes for biopharmaceutical active ingredients, so as to reduce the total time required before a new drug reaches the clinical trial phase, researchers are developing standardized processes for substance classes such as antibodies and cDNA.
Clinical Airway Research
Fraunhofer ITEM has many years of experience and expertise in the field of clinical airway research – with focus on asthma, COPD, and allergic rhinitis, and on interstitial lung diseases, idiopathic pulmonary fibrosis _ complemented by a unique state-of-the-art infrastructure for performing clinical trials – the Clinical Research Center Hannover.
Depending on your requirements, our services can cover either the complete process. You will benefit from competences and expertise accumulated over years in a broad range of projects on biotherapeutics – from recombinant proteins and glycoproteins to complex multimolecular structures such as viruses and cells. We provide you with the API and IMP and will guide you through the regulatory requirements to an approved IMP dossier for your drug candidate.
Our scientists have developed a wide range of challenge models to test the human response, e.g. to inhaled allergens. We have direct access to human samples such as bronchoalveolar lavage, sputum, serum, and plasma, and have our own immunological lab including flow cytometry, chip cytometry, and an MSD multiplex platform. A large database of both prescreened patients and healthy volunteers and a professional recruitment team ensure reliable time lines in the performance of clinical trials.
Fraunhofer ITEM has developed ex-vivo cultures of human explants and uses these for efficacy testing of new drugs. Ex-vivo lung explants are living, three-dimensional lung tissue slices, also referred to as precision-cut lung slices (PCLS). PCLS contain nearly all cells that are normally present in the lung.
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
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Premature babies who are born before their lungs have finished maturing often suffer from a lack of surfactant – a substance necessary for lung development. They are also particularly susceptible to illnesses of the respiratory organ, which have to be treated by means of inhalation.
However, the inhalation systems available are not geared to the needs of preterm infants and newborns. Researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM are working with partners to develop a system that would allow drugs to be administered as aerosols in an efficient and breath-triggered manner.
This would shorten therapy duration, thereby easing the strain on little bodies.
Researchers from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM have teamed up with colleagues from the Hannover Medical School (MHH) and Griffith University’s Institute for Glycomics (IfG) in Gold Coast, Australia, in the Fraunhofer International Consortium for Anti-Infective Research – iCAIR in brief.
They have set themselves the ambitious goal of developing novel anti-infective drugs.